STERLING, Va.--(BUSINESS WIRE)--July 17, 2006--WaveLight, Inc., (FWB:WLT) a subsidiary of WaveLight AG, today announced that it has received marketing clearance from the U.S. Food and Drug Administration (FDA) for the ALLEGRETTO WAVE Eye-Q excimer laser system. Delivering the fastest laser vision correction procedures available in the U.S., the 400 hertz ALLEGRETTO WAVE Eye-Q is the next generation of Wavefront Optimized technology designed to increase efficiency and enhance patient comfort.
The ALLEGRETTO WAVE Eye-Q was approved to correct myopia of up to -12D of with up to -6D astigmatism and hyperopia of up to +6D with up to 5D of astigmatism. This broad treatment range, simultaneous for both myopia and hyperopia, has been granted only once previously to the 200 hertz ALLEGRETTO WAVE in October 2003. Both Wavefront Optimized systems deliver specific ablation profiles based on each eye’s unique corneal asphericity to preserve the cornea’s natural shape. This has been shown to improve visual outcomes, particularly in dim light conditions.
“We are proud to introduce yet another Wavefront Optimized treatment approach to the US market,” said Max Reindl, CEO of WaveLight AG. “The ALLEGRETTO WAVE has remained the fastest laser available since its approval in 2003. Now, the 400 hertz system continues this approach and represents the fastest solution on the market today. It is especially ideal for high-volume practices and for treating patients that require high levels of correction.”
With a 400 hertz repetition rate, the ALLEGRETTO WAVE Eye-Q delivers one diopter of correction in just 2 seconds with a 6.5 mm optical zone. The reduction in treatment time provides a shorter, more comfortable procedure for the patient. It is particularly beneficial for treating high myopia, high astigmatism or other time-intensive procedures. For high volume practices, the increased speed of the ALLEGRETTO WAVE Eye-Q proves to be a valuable time saver.
WaveLight AG (ISIN DE 000 512 5603)
WaveLight AG, listed in Deutsche Borse AG’s Prime Standard since January 2003, develops, produces, and markets a high-quality, end-to-end product portfolio in the fields of ophthalmology and aesthetics. WaveLight’s market success is based on its innovative range of products that are the technology leaders in their areas of application and its broad-based sales network featuring both own sales channels and strategic partners. In the past fiscal year 2004/2005, WaveLight generated revenues of EUR 80.7 million and EBIT of EUR 8.8 million. Its average growth rate (CAGR) since 2000/2001 amounts to 35 percent for revenues and 63 percent for EBIT.
Further information on WaveLight is available at: www.wavelight.com/eyes.
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Disclaimer for Myopia:
a. Approval of the premarket approval application is for the WaveLight ALLEGRETTO WAVE(R) Eye-Q Excimer Laser System to perform LASIK treatments in patients 18 years of age or older for the reduction or elimination of myopic refractive errors up to -12.0 diopters (D) of sphere with and without astigmatic refractive errors up to -6.0 D; and in patients with documented evidence of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery. b. LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries. c. Approval of the application is based on clinical trials in the United States with 901 eyes treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%. d. The studies found that of the 844 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 3-month stability time point, 98.0% were corrected to 20/40 or better, and 84.4% were corrected to 20/20 or better without spectacles or contact lenses. e. The clinical trials showed that the following subjective patient adverse events were reported as “moderate to severe” at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: visual fluctuations (12.8% at baseline versus 28.6% at 3 months). f. Long term risks of LASIK for myopia with and without astigmatism beyond 12 months have not been studied. g. Note that the complete name for this ophthalmic laser is “WaveLight ALLEGRETTO WAVE(R) Eye-Q Excimer Laser System for laser assisted in situ keratomileusis (LASIK) treatments of myopic refractive errors up to -12.0 diopters (D) of sphere with and without astigmatic refractive errors up to -6.0 D at the spectacle plane.”
Disclaimer for Hyperopia:
a. Approval of the premarket approval application is for the WaveLight ALLEGRETTO WAVE(R) Eye-Q Excimer Laser System to perform LASIK treatments in patients 18 years of age or older for the reduction or elimination of hyperopic refractive errors up to +6.0 diopters (D) of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D; and in patients with documented evidence of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia.
b. LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries. c. Approval of the application is based on clinical trials in the United States with 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Accountability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was 69.9%. d. The studies found that of the 212 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 67.5% were corrected to 20/20 or better without spectacles or contact lenses. e. The study showed that the following subjective patient adverse events were reported as “much worse” by at least 1% of the subjects (in order of increasing frequency) at 6 months post final treatment: glare from bright lights (3%); night driving glare (4.2%); light sensitivity (4.9%); visual fluctuations (6.1%); and halos (6.4%). f. Long term risks of LASIK for hyperopia with and without astigmatism beyond 12 months have not been studied. g. Note that the complete name for this ophthalmic laser is “WaveLight ALLEGRETTO WAVE(R) Eye-Q Excimer Laser System for laser assisted in situ keratomileusis (LASIK) treatments of hyperopic refractive errors up to +6.0 diopters (D) of with and without astigmatic refractive errors up to 5.0 D with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D.”
Contact: WaveLight AG Katrin Teigeler, +49/9131/6186-217 Fax: +49/9131/6186-228 katrin.teigeler@wavelight.com or CoActive Public Relations Carmen Caricchio, 415-621-6626 Fax: 415-621-6636 carmen@coactivepr.com
Source: WaveLight, Inc.
